Barrier Neuro Sheet

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K760937 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Edge Protector, Barrier

  Class II

  FDA 510(k) K790306 Active Cleared 22 Feb 1979

• Barrier Pediatric/Incise Drape 450

  Class II

  FDA 510(k) K780839 Active Cleared 14 Aug 1978

• Barrier General Surgery Pack

  Class II

  FDA 510(k) K760807 Active Cleared 3 Nov 1976

• Barrier Antimicrobial Incise Drape

  Class II

  FDA 510(k) K820543 Active Cleared 22 Jul 1982

• Purge Line Unit

  Class II

  FDA 510(k) K790804 Active Cleared 25 May 1979

• Sterile Surgical Scrub Brush

  Class I

  FDA 510(k) K874653 Active Cleared 30 Dec 1987

See all devices from Surgikos, Inc. →

• What is the Barrier Neuro Sheet used for in neurosurgery?

  The Barrier Neuro Sheet is a surgical drape specifically designed to create a sterile barrier during neurosurgical procedures. Its primary function is to isolate the operative field, minimizing contamination risks and preserving aseptic conditions around neural tissues. This helps protect sensitive brain or spinal cord areas from external pathogens during surgery.

• Is the Barrier Neuro Sheet sterile when received, and how should it be handled?

  The Barrier Neuro Sheet is supplied as a non-sterile item and must be sterilized prior to use. It follows standard surgical drape protocols for sterilization, which typically include autoclaving or ethylene oxide treatment. Proper handling before sterilization—such as avoiding direct contact with surfaces or personnel—is critical to maintain its integrity and prevent contamination before the final sterilization step.

• Can the Barrier Neuro Sheet be reused, or is it intended for single-use only?

  The Barrier Neuro Sheet is intended for single-use only. Like most surgical drapes, it is designed to be discarded after one procedure to ensure patient safety and prevent cross-contamination. Reuse could compromise sterility and compromise the device’s ability to effectively isolate the operative field, posing risks to both patient and clinician.

• What storage and handling precautions should be taken for the Barrier Neuro Sheet?

  Storage and handling should adhere to standard surgical drape protocols to preserve the sheet’s integrity before sterilization. It should be kept in a clean, dry environment protected from dust, moisture, and direct sunlight. Avoid folding or bending the sheet excessively, as this could damage its adhesive properties or compromise its barrier function. Always follow manufacturer guidelines for packaging and expiration dates to ensure optimal performance.

• What regulatory classification and clearance does the Barrier Neuro Sheet hold?

  The Barrier Neuro Sheet is classified as a Class II General Hospital Device under FDA regulations and holds 510(k) clearance (K760937). It is determined to be substantially equivalent to a predicate device and is regulated under product code KKX. This classification reflects its role as a surgical drape used to maintain sterile conditions during neurosurgical procedures.